As I teach courses in PAT and QbD, I am struck by the division of responsibility within the industry. For instance, we still distinguish between an “R&D lab budget,” a “QC lab budget” as well as a “process analysis budget,” even though all may be used to analyze a single product or project.
This silo effect of considering each expenditure in isolation is not restricted to the pharma industry. As a card-carrying member of AARP, I recently came across a column in the organization’s bulletin on the topic of hospital emergency rooms, entitled, “What an Outrage!” At first, I thought it would be another rant by a cranky old-timer. But I read on.
The article explained how emergency room visits in central Texas were recently analyzed for patterns and, among the many findings, it was revealed that in the last six years just nine residents accounted for 2,678 visits to the ER. One patient visited an ER more than 100 times a year for four years! Since the average cost of an ER visit in the U.S. is roughly $1,000, these nine people cost Texas some $2.7 million over the nine years. All through the country, hospitals must bear these costs; many are closing their ERs to avoid bankruptcy. It was suggested (as one of the many facets of the President’s health care proposals) that clinics be set up to service patients with no insurance (instead of going to ERs). Critics said these clinics would cost too much (taxpayers’) money. The fact that the visits would cost around $50 per patient visit instead of $1,000 didn’t seem to register. Why? The monies were from different budgets, of course. Saving the hospitals, in the minds of opponents, didn’t justify subsidizing clinics. Silo effect?
OK, health care is too controversial. How about the energy problems we are having? In an article about new energy sources in my local newspaper, I detected another whiff of the silo effect. The article was about a newer technology that could save vast amounts of energy by fixing/improving/modernizing the power grid in the U.S. (Currently, we would rather have wars to gain more oil than find ways to conserve.) The current annual waste from the creation and distribution of electric power in the U.S., it noted, would power India, Germany, and Canada for an entire year.
Despite the fact that most engineers know solutions, there is political opposition to managing distribution, “sell-backs” from home power generating units (windmills, etc.), and mandating “smart appliances.” Everything from freedom of choice to restraint of trade is used to oppose wholesale changes in the way we generate, distribute, and consume power. Do I hear a silo approaching in stealth mode?
Which brings us back to the pharma industry: if a lab at ABC Pharma wishes to purchase, say, an NIR instrument for $50K, the lab manager is required to justify the purchase on the basis of current or projected applications. But rarely is there any hard glance at what the cost of one batch of drug recalled might cost! The lab manager is hit with a bogus “ROI” question: how much will be returned by the instrument?
In truth, zero would be a good guess. ABC Pharma will sell just as many sustained-release wingos as before, so there will be no more income generated. What needs to be examined—and this applies to all the cases I’ve mentioned so far—is, how much is the organic entity (ABC Pharma, the hospital system, the energy industry, in short: the taxpayer) going to benefit by making a change?
The same number of people will be sick in a given year, but the costs for those patients could drop substantially should the clinics be established to supplement ER’s. If the power grid were improved a mere 5%, it would be equivalent to eliminating the fuel and greenhouse gas emissions from 53 million cars. Considering the audits that started the PAT guidance in the first place, the Pharma industry was running at 3-5% efficiency; ANY improvement would save SOMETHING!
At one of my former employer’s, the drying of an API (narcotic) took one week per batch. This was largely due to having to cool the vessel, bleed off the vacuum, and then have a fully suited operator take a sample for Karl Fischer moisture. When NIR was added, the throughput was raised to two batches per week: a 100% increase in throughput. This simple investment was equivalent to adding a second dryer for 5% of the cost of a second dryer. The only reason it took as long as it did to place in operation was . . . it wasn’t in the budget for the year, while a second dryer was!
Einstein said that doing the same operation over and over in the same fashion while expecting a different result was the definition of insanity. Who knows? Maybe, if I watch the Super Bowl over a few more times, the Cardinals may finally win.